CSV Engineer for Medical Devices company in Cork, this role will also cover Limerick.
Computer Systems Validation Engineer - Cork
*Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local Procedures as they relate to Computer Systems/Software Validation activities.
*Participate on Divisional Validation Team to develop and revise Computer Systems/Software Validation Procedures and templates to ensure that current regulatory compliance and Company Objectives are maintained.
*Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures
*Represent validation from a Computer Systems/Software Validation perspective at both internal and external audits.
*Ensure that QE's and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
*Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for equipment/systems.
*Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
*Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
*Review/Approval of all Computer Systems/Software Validation Documentation.
*Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
*Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met.
*Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures
Skills an Responsibilites:
*Bachelor's Degree in Science /Engineering is required.
*Minimum of 3 to 4 years direct experience in a computer system/software validation role in either Medical device or Pharmaceutical Industry.
*A thorough working knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements.
*High level of PC skills required.
*The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
*Working Knowledge/experience of Risk Based Techniques.
*Excellent communication skills and attention to detail.
*An understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs an advantage.
*Have a good understanding of engineering and machine tool fundamentals.
*Source Code review experience a distinct advantage.
*Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
*Must be willing to work as part of a multi-site team, be able to travel as part of the job.
